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NCT06297226PHASE2Recruiting

Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Start Date

3/21/2024

Completion Date

6/30/2032

Summary

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT). * Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria. * Participants must have measurable disease during screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria * Active or history of central nervous system involvement with MM. * Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded. * Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

BIOLOGICAL

Arlocabtagene Autoleucel

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Conditions

Multiple Myeloma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294-3300

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)

Los Angeles, California 90095

United States

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California 94143

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

Northside Hospital

Atlanta, Georgia 30342

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Iowa

Iowa City, Iowa 52242

United States

The University of Kansas Cancer Center - Westwood

Westwood, Kansas 66205

United States

Norton Women's and Children's Hospital

Louisville, Kentucky 40207

United States

Local Institution - 0065

Baltimore, Maryland 21218

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of North Carolina Medical Center

Chapel Hill, North Carolina 27599-7305

United States

Local Institution - 0067

Charlotte, North Carolina 28204

United States

Oncology Hematology Care

Cincinnati, Ohio 45242

United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania 19107

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Local Institution - 0069

Austin, Texas 78704

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute

San Antonio, Texas 78229

United States

LDS Hospital

Salt Lake City, Utah 84143

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland 4029

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

St Vincent's Hospital

Melbourne, Victoria 3065

Australia

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602

Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo 663-8501

Japan

Chiba University Hospital

Chiba, 260-8677

Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

Japanese Red Cross Medical Center

Tokyo, 150-8935

Japan